%0 Journal Article
%A Schlenk, Richard
%A Lübbert, Michael
%A Benner, Axel
%A Lamparter, Alexander
%A Krauter, Jürgen
%A Herr, Wolfgang
%A Martin, Hans
%A Salih, Helmut R
%A Kündgen, Andrea
%A Horst, Heinz-A
%A Brossart, Peter
%A Götze, Katharina
%A Nachbaur, David
%A Wattad, Mohammed
%A Köhne, Claus-Henning
%A Fiedler, Walter
%A Bentz, Martin
%A Wulf, Gerald
%A Held, Gerhard
%A Hertenstein, Bernd
%A Salwender, Hans
%A Gaidzik, Verena I
%A Schlegelberger, Brigitte
%A Weber, Daniela
%A Döhner, Konstanze
%A Ganser, Arnold
%A Döhner, Hartmut
%T All-trans retinoic acid as adjunct to intensive treatment in younger adult patients with acute myeloid leukemia: results of the randomized AMLSG 07-04 study.
%J Annals of hematology
%V 95
%N 12
%@ 0939-5555
%C Berlin
%I Springer61936
%M DKFZ-2017-05570
%P 1931-1942
%D 2016
%X The aim of this clinical trial was to evaluate the impact of all-trans retinoic acid (ATRA) in combination with chemotherapy and to assess the NPM1 status as biomarker for ATRA therapy in younger adult patients (18-60 years) with acute myeloid leukemia (AML). Patients were randomized for intensive chemotherapy with or without open-label ATRA (45 mg/m(2), days 6-8; 15 mg/m(2), days 9-21). Two cycles of induction therapy were followed by risk-adapted consolidation with high-dose cytarabine or allogeneic hematopoietic cell transplantation. Due to the open label character of the study, analysis was performed on an intention-to-treat (ITT) and a per-protocol (PP) basis. One thousand one hundred patients were randomized (556, STANDARD; 544, ATRA) with 38 patients treated vice versa. Median follow-up for survival was 5.2 years. ITT analyses revealed no difference between ATRA and STANDARD for the total cohort and for the subset of NPM1-mutated AML with respect to event-free (EFS; p = 0.93, p = 0.17) and overall survival (OS; p = 0.24 and p = 0.32, respectively). Pre-specified PP analyses revealed better EFS in NPM1-mutated AML (p = 0.05) and better OS in the total cohort (p = 0.03). Explorative subgroup analyses on an ITT basis revealed better OS (p = 0.05) in ATRA for genetic low-risk patients according to ELN recommendations. The clinical trial is registered at clinicaltrialsregister.eu (EudraCT Number: 2004-004321-95).
%K Tretinoin (NLM Chemicals)
%F PUB:(DE-HGF)16
%9 Journal Article
%$ pmid:27696203
%2 pmc:PMC5093206
%R 10.1007/s00277-016-2810-z
%U https://inrepo02.dkfz.de/record/130491